Opioids are a type of medicine often used to help relieve pain. Opioids work by attaching themselves to specific proteins called opioid receptors, which are found in nerve cells in the brain, spinal cord, gastrointestinal tract, and other organs within the human body. When opiates attached to these receptors, they change how the brain perceives pain by creating feelings of pleasure and euphoria. The human brain is wired to record feelings of pleasure and euphoria, and cues the individual to take more and more of the drug. As a result, a user can become dependent on, and addicted to, opioids very quickly. Current estimates show that as many as 36 million users worldwide suffer from opioid addiction.
Opioid addiction quickly leads to adverse health effects such as dizziness, nausea, aches and pains, tremors, chills, vomiting, and constipation. In addition to these negative health effects, the user builds a tolerance to the positive effects of the opioid which can lead to overdose and death. In 2015, the Centers for Disease Control reported that drug overdoses accounted for 52,504 deaths in the United States, 63.1% of which involved and opioid.
As a result of the increased levels of addiction, prescription medications are typically controlled in a closed system of distribution which seeks to control the importation, manufacture, distribution, and dispensing of controlled substances. This closed system is designed to provide a discrete chain of custody for controlled substances, and ensure that those substances are used in accordance with a prescribed manner which is specific to a given quantity of the substance taken at defined intervals of time. This closed system effectively opens when a controlled substance is released into the hands of the patient or end-user. The end-user, while bound by the laws of use specified by the closed system, is largely free to operate on the honor system and trusted to follow the regimen specified by the prescription instructions.
Several unintended consequences arise from this honor system which include, but are not limited to; missed doses, over-doses, unused quantities of controlled substances, and access to controlled substances by non-authorized users. Further, well-meaning end-users often dispose of unused quantities of controlled substances into the wastewater supply where they contaminate water resources with unknown and poorly-studied consequences.
In the case of addictive substances such as opioids, an attractive nuisance is created whereby unauthorized users happen upon and ingest unused controlled substances and experience the euphoria associated with opioids and other strong pain medications. For many, this first experience leads to a downward spiral of abuse which tragically, and all too often, results in addiction, and a move to cheaper, more readily accessible street drugs like heroin. Deaths related to heroin and opioid abuse continue to spiral out of control, due in part, to the lack of control resulting from the current honor system of managing the distribution of controlled substances to end-users.
U.S. Pat. No. 7,978,5464 (De La Huerga) discloses a device which relies upon an electronic processor and communication with the end-user to remind of the proper dose, track usage, warn of drug interactions, but does not physically limit access to controlled substances. A further disadvantage of the device in De La Huerga is that the device relies upon separate consoles which would complicate adherence to regimens for end-users who are traveling or simply going about their daily lives, going to the market, or even visiting their physician.
U.S. Pat. No. 9,218,458 (Baarman) discloses another device that tracks usage, reminds and warns end users, using an additional electronic device in proximity with the invention before dispensing controlled substances. While this device moves to physically limit access, it requires an outboard device for user validation. Further, the invention automatically dispenses controlled substances according to a pre-defined regimen, but this may conflict with regimen instructions such as, “take as needed”, or, “take one or two tablets, as needed.”
United States Patent Application Publication No. 2014/0214200 (Chrusciel) controls dispensing “several non-individually packaged pills at a plurality of times”. The nature of providing for a “plurality of removable magazines” results in a device that is much larger than is conveniently portable and requires an end-user to move all of their controlled substances about as a single group. The use of rechargeable batteries, charged from a wall outlet further restricts portability.
U.S. Pat. No. 8,622,241 (Geboers) describes a device where tablets or capsules are dispensed at preset intervals and quantities from columns of loose tablets, pills or capsules. The device is mechanical, or electromechanical, but requires an outboard unit containing a processor and communication device to track end-user behavior and to respond to flexible requirements embodied in many medication regimens.
U.S. Pat. No. 9,283,150 (Bujalski) describes a device that relies upon a mechanical timer to release controlled substances in accordance with a pre-defined regimen. End-users are alerted when the time interval is reached, but there is limited flexibility in managing instructions such as, “Take one or two tablets as needed”. This invention lacks the ability to record and communicate a history of usage, and the ability to display remaining dosages, or time to next dosage.
Thus, there is a long-felt need for a tablet and capsule dispenser that prevents access to tablets and capsules except as specified by a pre-defined regimen and has the ability to record and communicate a history of usage, display remaining dosages, display time to next dosage, and prevent early access to the next dosage.